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| ID | Type | Description | Link |
|---|---|---|---|
| CRUK-FORT | |||
| CRUK-BRD/05/84 | |||
| 2005-002416-19 | EudraCT Number | ||
| ISRCTN65687030 | |||
| EU-20601 |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different regimens of low-dose radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are randomized to one of two treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 Gy | Experimental | 4 Gy in 2 fractions |
|
| 24 Gy | Active Comparator | 24 Gy in 12 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local progression-free interval in irradiated field | Time form randomisation to tumour progression within the irradiated field | up to 5 years after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | at 4 weeks after randomization | |
| Late toxicity | from 12 weeks after randomisation up to 5 years | |
| Tumor response in irradiated area at 12 weeks after randomization |
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DISEASE CHARACTERISTICS:
Histologically confirmed follicular or mmarginal zone non-Hodgkin's lymphoma (NHL)
Radiotherapy is indicated for curative treatment of stage IA or IIA disease OR palliation due to tumor bulk or anatomical position
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research UK and University College London Cancer Trials Centre | London | England | W1T 4TJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33539729 | Derived | Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1. | |
| 24572077 |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| at 12 weeks after randomization |
| Overall survival | up to 5 years after randomisation |
| Health economic assessment | up to 5 years after randomisation |
| Derived |
| Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24. |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |